Back to results

Oculomotor Assessment of Traumatic Brain Injury (TBI)

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neuro Kinetics IPAS

Oculogica EyeBox

SyncThink EyeSync Device

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring oculomotor testing

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Must be DEERS eligible (military)
Must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes).
Must be able to provide written informed consent.
Must be able to read and understand questionnaires and consent forms.
Must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease.

Control Group - No history of TBI or any history of severe or penetrating TBI

TBI Group - Must have a documented history of a TBI occurring within the last 10 years.

Exclusion Criteria:

Current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure).
Current or previous ocular disease/injury, including: Glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc.
History of vestibular disorder (e.g., with symptoms of clinical vertigo)
Binocular vision not correctable to 20/40 for near distance
Use of tobacco or caffeinated products less than four hours before test session
Consumption of alcohol within past 24 hours

Sites / Locations

National Intrepid Center of Excellence

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

TBI Group

Control Group

Arm Description

Subjects with history of TBI will undergo testing with all three devices.

Subjects with no history of TBI will undergo testing with all three devices.

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC)

Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)

Secondary Outcome Measures

Full Information

NCT ID

NCT03156010

First Posted

May 11, 2017

Last Updated

August 21, 2023

Sponsor

Walter Reed National Military Medical Center

Collaborators

Neurolign, Sync-Think, Inc., Oculogica, Inc., TBICoE, United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT03156010

Brief Title

Oculomotor Assessment of Traumatic Brain Injury (TBI)

Official Title

Oculomotor Assessment of Traumatic Brain Injury (TBI)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 18, 2017 (Actual)

Primary Completion Date

April 19, 2023 (Actual)

Study Completion Date

April 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walter Reed National Military Medical Center

Collaborators

Neurolign, Sync-Think, Inc., Oculogica, Inc., TBICoE, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the proposed study is to compare the sensitivity and specificity of three oculomotor test devices in normal subjects versus subjects with history of TBI. The study is designed as a prospective research project in which a group of 120 normal controls without a history of TBI will be compared to another group of 120 participants (total of 240) who have a confirmed history of TBI. Each participant will complete the TBI assessment protocol for each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the devices will be counter-balanced across participants. Participants will also be screened for vestibular migraine and visual vertigo, which are two conditions that influence oculo-vestibular perception in normal and TBI patients and might influence the results from the three oculomotor devices. Data from each device will be utilized to perform AUC analyses to determine the respective sensitivity and specificity for each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

oculomotor testing

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TBI Group

Arm Type

Other

Arm Description

Subjects with history of TBI will undergo testing with all three devices.

Arm Title

Control Group

Arm Type

Other

Arm Description

Subjects with no history of TBI will undergo testing with all three devices.

Intervention Type

Device

Intervention Name(s)

Neuro Kinetics IPAS

Intervention Description

Testing with PAS device

Intervention Type

Device

Intervention Name(s)

Oculogica EyeBox

Intervention Description

Testing with Oculogica EyeBox device

Intervention Type

Device

Intervention Name(s)

SyncThink EyeSync Device

Intervention Description

Testing with SyncThink EyeSync device

Primary Outcome Measure Information:

Title

Area Under the Curve (AUC)

Description

Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)

Time Frame

Single test session (1.5 hours) - all testing performed at time of study enrollment, will be reported at conclusion of data collection as all data is required to generate AUCs.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

All participants must be DEERS eligible, no exceptions! Inclusion Criteria: Must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes). Must be able to provide written informed consent. Must be able to read and understand questionnaires and consent forms. Must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease. Control Group - No history of TBI or any history of severe or penetrating TBI TBI Group - Must have a documented history of a TBI occurring within the last 10 years. Exclusion Criteria: Current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure). Current or previous ocular disease/injury, including: Glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc. History of vestibular disorder (e.g., with symptoms of clinical vertigo) Binocular vision not correctable to 20/40 for near distance Use of tobacco or caffeinated products less than four hours before test session Consumption of alcohol within past 24 hours

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis French, PsyD

Organizational Affiliation

NICoE

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Intrepid Center of Excellence

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared. All data from project will be shared in de-identified format as group data, not IPD.

Learn more about this trial

Oculomotor Assessment of Traumatic Brain Injury (TBI)

We'll reach out to this number within 24 hrs